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The Russian government will allocate additional 23 billion roubles ($305 million) for the procurements of high-priced imported drugs as part of 14 high-cost nosologies (VZN) state program, reports The Pharma Letter’s local correspondent. 25 April 2022
Pharmaceutical
Swiss pharma giant Roche kicked off the European first-quarter 2022 financial results reporting for the sector today, stating that group sales had increased 11% at constant exchange rates (CER) and 10% in Swiss francs to 16.45 billion francs ($15.75 billion). This was slightly above a market consensus of about 16 billion francs. 25 April 2022
Biotechnology
Global Market Insights (GMI) has predicted 5% compound annual growth rate (CAGR) in the global hemophilia market between 2022 and 2028. 20 April 2022
Biotechnology
US biotech Nektar Therapeutics lost 23% of its market value on Monday. 19 April 2022
Biotechnology
In a filing with the US Securities and Exchange Commission (SEC), Boston-based rare disease specialist Imara has disclosed savage job cuts as part of an extensive restructuring. 19 April 2022
Biotechnology
US biotech TG Therapeutics saw its shares plunge almost 32% to $6.03, after it announced the voluntary withdrawal of the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) - combination referred to as U2 - for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). 19 April 2022
Biotechnology
Among notable news last week, US biotech Seagen won a $41.8 million award through a US District Court ruling in its patent dispute with Japan’s Daiichi Sankyo over cancer drug Enhertu. USA-based Veru scored a big hit with Phase III data for its COVID-19 treatment candidate sabizabulin. On the M&A front, UK pharma major GlaxoSmithKline last Wednesday announced a $1.9 billion acquisition of Sierra Oncology, along with its myelofibrosis candidate momelotinib. Also announcing an M&A deal last Wednesday was specialty pharma company Halozyme Therapeutics, with a $960 million bid for Antares Pharma. 17 April 2022
Biotechnology
Danish biotech Genmab and the USA’s AbbVie have announced top-line results from the first cohort of the EPCORE NHL-1 Phase I/II, clinical trial evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody. 15 April 2022
Biotechnology
Not all that many things have gone well for US biotech bluebird bio in recent years, but the company had some good news this week in the shape of a draft report from the Institute for Clinical and Economic Review (ICER). 14 April 2022
Biotechnology
China-based biotech BeiGene has announced results from the Phase III ALPINE trial showing BTK inhibitor Brukinsa (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 April 2022
Biotechnology
US biopharma company Sierra Oncology saw its shares leap nearly 37% to $ 54.05 in pre-market trading today, as it was revealed that it has agreed to be acquired by UK pharma major GlaxoSmithKline. 13 April 2022
Biotechnology
Biotech major Gilead Sciences has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. 12 April 2022
Biotechnology
Danish firm Genmab was trading nearly 4% lower on Friday afternoon after the company lost out in a dispute with the Johnson & Johnson subsidiary Janssen. 8 April 2022
Biotechnology
Chinese clinical-stage biotech Shenzhen Pregene Biopharma and CellPoint, a Dutch cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), have entered an exclusive license agreement for the development and commercialization of PRG-1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the USA. 7 April 2022
Biotechnology
Shares of US drug developer Imara closed down 22% at $1.27 yesterday having tanked as much as 34%, after it announced disappointing results from interim analyses of its Ardent Phase IIb clinical trial of tovinontrine (IMR-687) in patients with sickle cell disease (SCD) and Forte Phase IIb clinical trial of tovinontrine in patients with beta-thalassemia. 6 April 2022
Biotechnology
Swiss antibody-drug conjugate specialist ADC Therapeutics today announced that a permanent J-code, J9359, has been issued for Zynlonta (loncastuximab tesirine-lpyl) by the US Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2022. 4 April 2022
Biotechnology
Ondexxya (recommend andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 29 March 2022
Biotechnology
The European Medicines Agency has accepted the Marketing Authorization Application (MAA) under accelerated assessment for etranacogene dezaparvovec (EtranaDez), a novel gene therapy candidate for the treatment of hemophilia B. 28 March 2022
Biotechnology
Clinical trial news last week included ADC specialist ImmunoGen releasing data from the SORAYA trial of its mirvetuximab soravtansine (Mirasol) that did not impress investors. On the regulatory front, Bristol Myers Squibb gained US Food and Drug Administration approval for a new metastatic melanoma treatment Opdualag, a combination of nivolumab and relatlimab. Also, MEI Pharma and Kyowa Kirin’s hopes of an early approval from the FDA for their P13K inhibitor zandelisib suffered a set back last Thursday. Meantime, at its vaccines day presentation, Moderna upped expectations for its COVID-19 vaccines. 27 March 2022
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval at its March 2022 meeting. 25 March 2022
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
UK drugmaker GSK might be trading lower following Thursday’s nomination of vaccine sceptic Robert F Kennedy Jr as the USA’s next health secretary, but the day brought good news for the group elsewhere in the business. 15 November 2024
Biotechnology
Adaptimmune Therapeutics reported promising data Wednesday from its pivotal Phase II trial of lete-cel in certain solid tumors with few effective treatments. 14 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Biotechnology
Syndax Pharmaceuticals has announced that its Phase II AUGMENT-101 trial of experimental drug revumenib achieved its primary endpoint. 13 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Ayvakyt (avapritinib) from USA-based Blueprint Medicines. 6 November 2024
Biotechnology
French drugmaker Sanofi has revealed the results from the Phase III LUNA 3 trial of rilzabrutinib, an oral bruton tyrosine kinase (BTK) inhibitor, in persistent or chronic immune thrombocytopenia (ITP). 6 November 2024
Biotechnology
Beam Therapeutics will detail new clinical and preclinical data on its sickle cell disease (SCD) therapies at the upcoming American Society of Hematology (ASH) meeting. 6 November 2024
Pharmaceutical
An impressive set of quarterly financial results and an improved outlook for the rest of the year were announced by Bristol Myers Squibb on Thursday. 31 October 2024
Biotechnology
Maryland, USA–based glycobiology specialist GlycoMimetics has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. 30 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
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